Director IT Quality Management CSV Operations Clinical Regulatory Enterprise Information Management and Data Integrity

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol Myers Squibb is a global biopharmaceutical company committed to transforming patients’ lives through science. At the core of that mission are the talented individuals who contribute their “unique” skillsets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we’re looking for talented professionals like you to join our team. What unique gene will you bring?

Responsibilities:


Responsible for Computer System Validation activities executed for portfolio of IT capabilities across all in scope functional areas to ensure 'fit for use' before release to production environment.

Lead a team to execute CSV for IT Capability projects ensuring efficiency, consistency, quality of work and compliance with external regulations and internal procedures.

Collaborate with IT Delivery leads, business users, and Global Quality function to ensure CSV projects are executed in accordance with internal procedures.

Own and oversee the Data Integrity compliance program to ensure enterprise systems are in alignment with internal expectations and relevant governmental regulations and guidelines related to Data Integrity.

Ensure Data Integrity requirements are defined and embedded within CSV procedures and practices.

Ensure effective and efficient quality strategies for compliance and validations strategies are defined across all in scope areas and related technology solutions.

Lead programs with high risk and complexity and develop validation strategy for project execution.

Partner with Enterprise Data Governance and Enterprise Architecture to ensure alignment of principles while identifying opportunities for improvement focusing on Data Management and Data Lake capabilities





Applies understanding of key business drivers to accomplish team objectives and influence work across matrixed teams and ensures adherence to software development practices, compliance, and key IT controls.





Anticipates business and industry challenges and recommends best practices-based solutions to improve products, processes, systems

Identify and implement continuous improvement through enhanced technology solutions that improve digitization, compliance and productivity.


Qualifications:


Bachelors degree or equivalent, MBA/Masters degree preferred, in computer science, engineering, life science or related field.

10 years of relevant experience, experience managing/overseeing CSV projects.

Expertise in CSV, GAMP, Electronic Records/Electronic Signature regulations, and related health authority regulations and guidelines

Understanding of global pharmaceutical / BioPharma industry environments and competitive forces.

Skills to operate in a highly matrixed organization. Ability to effectively build alignment and influence others in a matrix environment.

Strong leadership and supervisory skills

Decisive decision making capabilities.

Demonstrated ability to influence and work across multi-discipline teams.

Excellent interpersonal and teamwork skills.

Understanding of organizational dynamics of a global corporation, operating culture, effective work styles, and achieving results in a changing environment.

Ability to effectively communicate to a diverse audience at multiple levels across the organization.

Strong planning, organization, negotiation, and influencing skills.

Strong interpersonal and communication skills for effectiveness in meetings, presentations and in written form.

Knowledgeable in Software Development Lifecycle (SDLC) and demonstrated ability to execute and organize effectively across portfolio of IT capabilities and programs.


Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

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